The Future of E-cigarettes Guided be Regulation USA and Europe
Souring from speech made by Mr Ray Story , Chief Executive Officer of Tobacco Vapor Electronic Cigarette Association ,Cecmol China ECIG Forum ,2014/9/2
Ladies and Gentlemen,
It is a pleasure and an honour for me to be speaking to you today and I would like to thank the organisers of this conference for the invitation. This conference brings together many distinguished executives of the electronic cigarette industry. The fact that we are gathered with so many today is a token of the truly revolutionary growth of this industry and of the incredible potential that is still ahead of us for this product that provides smokers with a viable alternative to conventional tobacco products.
Those of you who know me, and I am pleased to see so many friends and colleagues today, know I am not a newcomer to this industry. I came to this industry many years ago when ecigarettes were not as present and appreciated as now and I take pride in the fact that I have been contributing to building up the industry as well as the regulatory framework in different parts of the world.
I am the owner of the UTVG, a leader in the development, manufacturing and marketing of e-cigarettes in primarily the U.S. and Europe. In my capacity as CEO of “Smoking Everywhere” I
brought the initial legal challenge FDA against the U.S. Food and Drug Administration (FDA) in 2009 when several shipments of my products were confiscated by the FDA. Thus began a long legal and regulatory history with which many of you are well familiar.
Today I want to focus on my role as the founder and chief executive of the Tobacco Vaporizer Electronic Cigarette Association, in short TVECA.
TVECA is the only truly global e-cigarette association, representing manufacturers, distributors, marketers and importers of a variety of e-cigarette products constituting a majority of the e cigarette market world-wide. TVECA represents businesses and individuals from across the United States, as well as many of the 28 Member States of the European Union (EU).
TVECA has been intimately involved in the regulation of e cigarettes both in the U.S. and in the European Union (EU).
As the CEO of the UTVG, a founding member of the TVECA, I also launched the legal challenge to the proposed 2011 ban on e cigarettes by the Dutch Ministry of Health, resulting in a 2012 Court of The Hague decision overturning the ban.
Subsequent to this decision, TVECA worked closely with European Union Institutions on e cigarette regulation, ultimately resulting in adoption of the EU’s Revised Tobacco Products Directive (TPD), regulating e-cigarettes for the first time in a clear, logical and responsible manner. The TPD governs the manufacture, presentation, advertisement and sale of tobacco vaporizer , dry herb vaporizer products (now including e-cigarettes) in the European Union.
More than 10 years after the adoption of the first European Union’s Tobacco Products Directive in 2001, new scientific and market developments in the tobacco sector made it necessary to update the existing regulatory framework to bring it in line with the new conditions and requirements. Besides the objective to improve the functioning of the internal market for tobacco and related products and ensure high health and safety standards, the revision also set out to provide, for the first time, a regulatory framework for electronic cigarettes, which had not been regulated specifically under prior EU legislation.
At the time of the beginning of the TPD revision, e-cigarettes faced varying regulatory frameworks across the EU, with some Member States regulating e-cigarettes as a consumer or a tobacco vaporizer product, and others as a medicine. This variety of different approaches caused regulatory fragmentation and undermined the principles of the EU Single Market, prompting the European
Commission to propose a way to uniformly regulate e-cigarettes.
It took roughly one year from the Commission’s initial proposal to regulate e-cigarettes as pharmaceutical products until the EU Member States and the European Parliament agreed to regulate them as a distinct category within the TPD. TVECA was instrumental in building the credibility of the e-cigarette industry in Europe, assisting EU institutions in reaching a constructive compromise where e-cigarettes would be both widely available to consumers as a less harmful alternative to conventional tobacco vaporizer products while complying with strict quality, safety and reporting obligations in the interests of consumers and society at large.
TVECA believes the result in the EU, while not perfect, does represent a solid, fact- and evidence-based approach to the regulation of e-cigarettes, balancing real public health concerns with respect for consumers and commerce.
As you well know, EU regulations tend to take a more conservative approach in favour of protecting consumers compared to other parts of the world. The final TPD agreement honours this approach, and in that respect serves as a useful model for U.S. regulators. This is also what the TVECA has written in its official submission to the FDA in response to its proposed so-called Deeming Rule earlier this year. We believe the U.S. should seek to harmonise its regulations with the EU’s TPD.
We also believe that recent regulatory experience in the EU and now in the U.S. can in many aspects be a source for other parts of the world to follow good practice and to avoid pitfalls we encountered and are still encountering in our ongoing dialogue with politicians and regulators.
In this respect I am following with great interest the developments in China and I would like to reiterate here publicly what I have said to some of you involved in the Chinese regulatory framework for e-cigarettes: the TVECA is offering our knowledge and experience to you.